Evidence map›Paper›PMID 21845389›Full record

SynthesisPsychopharmacology2012

The safety of studies with intravenous Δ⁹-tetrahydrocannabinol in humans, with case histories.

Michelle Carbuto, R Andrew Sewell, Ashley Williams, Kim Forselius-Bielen, Gabriel Braley, Jacqueline Elander, Brian Pittman, Ashley Schnakenberg, Savita Bhakta, Edward Perry and 3 more

Abstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Psychopharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Δ9-THC Disrupts Gamma (γ)-Band Neural Oscillations in Humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
    Trial
  5. Trial
  6. Dose-related modulation of event-related potentials to novel and target stimuli by intravenous Δ⁹-THC in humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2012
    Trial
  7. Article
  8. Review
  9. Article
  10. Cannabis Extract Composition Determines Reinforcement in a Vapor Self-Administration Paradigm.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2020
    Article
  11. Vaporized Cannabis Extracts Have Reinforcing Properties and Support Conditioned Drug-Seeking Behavior in Rats.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2020
    Article
  12. Article
  13. Toward a Translationally Relevant Preclinical Model of Cannabis Use.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2018
    Article
  14. Article
  15. Review
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Michelle CarbutoPsychiatry Service, VA Connecticut Healthcare System, 116A, VA Connecticut Healthcare System, 950 Campbell Avenue, West Haven, CT 06516, USA.
R Andrew Sewell
Ashley Williams
Kim Forselius-Bielen
Gabriel Braley
Jacqueline Elander
Brian Pittman
Ashley Schnakenberg
Savita Bhakta
Edward Perry
Mohini Ranganathan
Deepak Cyril D'Souza
Yale THC Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleDelta-9-tetrahydrocannabinol (THC) is one of the few cannabinoid receptor ligands that can be used to probe the cannabinoid system in humans. Despite increasing interest in the cannabinoid receptor system, use of intravenous THC as a research tool has been limited by concerns about its abuse liability and psychoactive effects.

objectivesThis study aims to evaluate the safety of all intravenous THC studies conducted at this center for the past 13 years.

methodsIncluded were 11 studies with 266 subjects (14 schizophrenia patients and 252 healthy subjects, of whom 76 were frequent cannabis users), 351 active THC infusions, and 226 placebo infusions. Subjects were monitored for subjective and physical adverse events and followed up to 12 months beyond study participation.

resultsThere was one serious and 70 minor adverse events in 9.7% of subjects and 7.4% of infusions, with 8.5% occurring after the end of the test day. Nausea and dizziness were the most frequent side effects. Adverse events were more likely to be associated with faster infusion rates (2-5 min) and higher doses (>2.1 mg/70 kg). Of 149 subjects on whom long-term follow-up data were gathered, 94% reported either no change or a reduction in their desire to use cannabis in the post-study period, 18% stated that their cannabis use decreased, and 3% stated that it increased in the post-study period.

conclusionsWith careful subject selection and screening, risk to subjects is relatively low. Safeguards are generally sufficient and effective, reducing both the duration and severity of adverse events.

Indexed as

Drug-Related Side Effects and Adverse ReactionsAdolescentAdultAnxietyDronabinolFemaleHumansMaleMarijuana SmokingMiddle AgedParanoid DisordersRandomized Controlled Trials as TopicTime FactorsYoung AdultDronabinol

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.